Associate Manager - Cellular Therapy Manufacturing Operations

Location
Cambridge, MA, United States
Posted
Sep 20, 2018
Ref
1287257
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

About the role:
  • Be the primary point of contact with contract manufacturing organizations (CMOs) and manage day-to-day operations
  • Provide technical support of GMP manufacturing runs for ongoing clinical studies carried out by contract manufacturing organizations (CMOs)
  • Work closely with QA and CMOs as applicable for successful resolution of deviations, CAPAs, Change Controls, etc.
  • Manage timelines and deliverables for technology transfer to CMOs including raw material and equipment procurement
  • Conduct onsite or offsite training of contract manufacturing personnel on manufacturing processes
  • Work with and develop training curricula and module content for CMO personnel
  • Work closely with internal stakeholders to map out and execute process improvement activities to drive alignment, simplification and cost reduction
  • Own and drive to conclusion change controls associated with improvements across numerous processes
  • Be the person in plant for process engineering or training runs
  • Participate in internal technology transfer activities, planning meetings and interact effectively with cross functional departments
  • Up to 10-30% travel with frequent weekend work

About you:
  • BS/MS with 5 - 7 years of experience in pre-clinical development, or cGMP manufacturing of clinical and/or commercial programs, with experience in cellular and gene therapies a significant plus
  • Experience working with CMOs, and experience conducting tech transfers highly desirable
  • Good understanding of applicable regulations and standards (e.g., GMP, and AABB)
  • Prior cGMP manufacturing experience for clinical-stage cell or gene therapies is highly favorable
  • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
  • Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
  • Independently motivated, detail oriented and good problem-solving ability
  • Proficient with timeline development and project tracking using MS Project is a plus
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE.We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a fast growing company provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.